The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.

Device Description

The P-ARTIS CT scanner is an adaptation of the cleared Philips AcQSim-Multislice-CT scanner (K033357, aka Brilliance Big Bore 16 Slice CT scanner) for imaging patients in a seated position. This adaptation is designed by P-Cure in agreement with Philips Medical Systems (Cleveland), Inc. P-Cure has developed a patient Chair and a wall mounted Sliding Platform that is responsible for moving the Gantry up and down along the center axis of the Gantry opening while the patient is seated. The Gantry motion serves to position the scan plane at the start of the region to be scanned and to increment the position of the scan plane during the scan itself.

Being a modification of the cleared Philips AcQSim CT scanner, the principal mode of operation and the essential principles of operation are the same as those of the AcQSim CT scanner. A difference yet exists in the implementation of the scan plane incrementation: instead of moving the table with the lying patient In and Out of the scan plane, the P-ARTIS moves the Gantry scan plane Up and Down over the seated patient. The relative motion is however considered identical between the two systems.

AI/ML Overview

The provided text describes the P-ARTIS CT scanner, a modified version of an existing CT system (Philips AcQSim-Multislice-CT scanner), adapted for scanning patients in a seated position. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than detailed performance criteria or a standalone clinical study for a novel AI/device.

Therefore, much of the requested information regarding acceptance criteria, study design for AI/human-in-the-loop performance, and detailed ground truth establishment is not explicitly available in this document. The document describes a device modification rather than a new AI or diagnostic algorithm, and as such, the testing described is primarily focused on safety, performance comparability to the predicate, and functionality of the physical system.

However, based on the provided text, I can extract the following information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of quantitative acceptance criteria with corresponding device performance metrics for diagnostic accuracy (e.g., sensitivity, specificity). Instead, it states:

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Safety and Performance Compliance	"Tests results indicated that the P-ARTIS CT scanner performs according to its specifications and to the requirements established for a CT scanner."
Electrical Safety	Passed tests according to AAMI/ANSI ES60601-1.
Electromagnetic Compatibility (EMC)	Passed tests according to IEC 60601-1-2 standards.
Imaging Capabilities & Accuracy (Bench Testing)	"Bench testing, performed using phantoms and demonstrated the imaging capabilities and accuracy of the P-ARTIS CT scanner and its comparability to the Philips AcQSim predicate."
Software Verification & Validation	Verified and validated.
Substantial Equivalence	The P-ARTIS CT scanner is "as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing, performed using phantoms." This implies physical phantoms were used for testing, not patient data in the traditional sense of a clinical trial.
No specific sample size for a "test set" of patient data is mentioned, nor is there information about data provenance (country of origin, retrospective/prospective). This is consistent with a 510(k) for a device modification without a new clinical indication requiring patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth in this context would relate to the physical properties measured by phantoms during bench testing, not expert interpretation of clinical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided, as this was not a study evaluating human interpretation or diagnostic accuracy on clinical cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was described. The device is a CT scanner, not an AI-assisted diagnostic tool as understood in the context of MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device being reviewed is a CT scanner system, not a standalone algorithm in the typical sense of AI or image processing software. Its performance verification involved bench testing with phantoms and demonstration of comparability to its predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Bench testing," the ground truth was based on the known physical properties and measurements from phantoms.

8. The sample size for the training set

Not applicable/Not provided. This is a modified CT scanner, not an AI model requiring a training set of data.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2016

P-Cure Ltd. % Merav Yarmus, Ph.D. Senior Clinical & Regulatory Affairs Expert Biomedical Strategy 155 Bialik St. Ramat-Gan, 5252346 ISRAEL

Re: K160611 Trade/Device Name: P-ARTIS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 6, 2016 Received: July 11, 2016

Dear Dr. Yarmus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K160611

Device Name P-ARTIS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

510(K) Number K160611

Applicant's Name:

P-Cure Ltd. 12 Abba Hillel Street Lod, 7129409, Israel Tel: +972-8-6373030 Fax: +972-8-6373090

Contact Person:

Merav Yarmus, Ph.D. Biomedical Strategy (2004) Ltd. 10 Ha'ta'as Street Ramat Gan, 5252346, Israel Tel: +972-3-6123281 Fax: +972-3-6123282 Mail: merav@ebms.co.il

Date Prepared: February, 2016 Trade Name: P-ARTIS Classification Name: Computed Tomography X-ray System Regulation Number: 892.1750 Product Code: JAK Device Class: II Panel: Radiology

Predicate Devices:

. AcQSim-Multislice-CT CT scanner [Philips Medical Systems] cleared under K033357 (regulation: 892.1750, Computed Tomography X-ray System, Class II, Product Code: JAK)
Somatom Plus 4 with Sliding Gantry Option [Siemens Corp.] cleared under K991600 . (regulation: 892.1750, Computed Tomography X-ray System, Class II; Product Code: JAK)

Intended Use / Indication for Use:

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equipment, patient, and equipment supports, components and accessories. The system is intended for scanning patients while seated.

Device Description:

Substantial Equivalence:

The P-ARTIS CT scanner as well as its two predicates, the AcQSim system and the Somatom system, are all CT scanners intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The adaptation of the P-ARTIS system for scanning seated patients has no effect on its fundamental intended use or indications for use nor does it alter the P-ARTIS diagnostic characteristics or quality attribute as a CT scanner.

The P-ARTIS system is basically its predicate device, the Philips AcQSim system, that has been modified by P-Cure in order to enable imaging patients in a seated position. Consequently, the P-ARTIS system is comprised of hardware (HW) and software (SW) components that are highly similar to those of its AcQSim system predicate. The modifications introduced relate to the configurational changes that apply for scanning a seated patient and they do not change the fundamental control elements and processes. Also, the same key operational procedures and mode of operation apply to both systems and the types of acquired images are shared: Surview, Axial, and Helical. As a result, the essential functionality, capabilities, and output of the P-ARTIS system as a CT scanner are kept as its AcOSim predicate.

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Both the P-ARTIS system and its Siemens predicate (i.e., the Somatom system) consist of a moving gantry rather than a moving patient table. The scan control in the Somatom system is designed to move the gantry relative to the table instead of moving the table relative to the gantry. In the P-ARTIS system, a patient chair is included instead of a CT table, and the gantry is movable vertically to the chair. That is, in both the Somatom and the P-ARTIS systems, the gantry movement functions like the movable table in other CT scanners. While the direction of the gantry movement is different as well as the type of patient support (table vs. chair), the same fundamental concept of having a movable gantry that moves along a stationary patient support is applied in both systems.

A comprehensive testing program was performed in order to demonstrate the safety and performance of the P-ARTIS CT scanner. The testing program included the following main aspects:

트 Electrical safety and electromagnetic compatibility testing, performed in an external laboratory according to AAMI/ANSI ES60601-1 and IEC 60601-1-2 standards.
. Bench testing, performed using phantoms and demonstrated the imaging capabilities and accuracy of the P-ARTIS CT scanner and its comparability to the Philips AcQSim predicate.
. Software verification and validation testing

Tests results indicated that the P-ARTIS CT scanner performs according to its specifications and to the requirements established for a CT scanner.

Conclusion:

P-Cure Ltd. believes that the P-ARTIS CT scanner is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.